Subjective assessment and IOTA ADNEX model in evaluation of adnexal masses in patients with history of breast cancer.

OBJECTIVE: To evaluate the performance of subjective assessment and the Assessment of Different NEoplasias in the adneXa (ADNEX) model in discriminating between benign and malignant adnexal tumors and between metastatic and primary adnexal tumors in patients with a personal history of breast cancer. METHODS: This was a retrospective single-center study including patients with a history of breast cancer who underwent surgery for an adnexal mass between 2013 and 2020. All patients had been examined with transvaginal or transrectal ultrasound using a standardized examination technique and all ultrasound reports had been stored and were retrieved for the purposes of this study. The specific diagnosis suggested by the original ultrasound examiner in the retrieved report was analyzed. For each mass, the ADNEX model risks were calculated prospectively and the highest relative risk was used to categorize each into one of five categories (benign, borderline, primary Stage I, primary Stages II-IV or metastatic ovarian cancer) for analysis of the ADNEX model in predicting the specific tumor type. The performance of subjective assessment and the ADNEX model in discriminating between benign and malignant adnexal tumors and between primary and metastatic adnexal tumors was evaluated, using final histology as the reference standard. RESULTS: Included in the study were 202 women with a history of breast cancer who underwent surgery for an adnexal mass. At histology, 93/202 (46.0%) masses were benign, 76/202 (37.6%) were primary malignancies (four borderline and 72 invasive tumors) and 33/202 (16.3%) were metastases. The original ultrasound examiner classified correctly 79/93 (84.9%) benign adnexal masses, 72/76 (94.7%) primary adnexal malignancies and 30/33 (90.9%) metastatic tumors. Subjective ultrasound evaluation had a sensitivity of 93.6%, specificity of 84.9% and accuracy of 89.6%, while the ADNEX model had higher sensitivity (98.2%) but lower specificity (78.5%), with similar accuracy (89.1%), in discriminating between benign and malignant ovarian masses. Subjective evaluation had a sensitivity of 51.5%, specificity of 88.8% and accuracy of 82.7% in distinguishing metastatic and primary tumors (including benign, borderline and invasive tumors), and the ADNEX model had a sensitivity of 63.6%, specificity of 84.6% and similar accuracy (81.2%). CONCLUSIONS: The performance of subjective assessment and the ADNEX model in discriminating between benign and malignant adnexal masses in this series of patients with history of breast cancer was relatively similar. Both subjective assessment and the ADNEX model demonstrated good accuracy and specificity in discriminating between metastatic and primary tumors, but the sensitivity was low. © 2023 International Society of Ultrasound in Obstetrics and Gynecology.

The role of brachytherapy (interventional radiotherapy) for primary and/or recurrent vulvar cancer: a Gemelli Vul. Can multidisciplinary team systematic review

Objective The aim of our systematic review was to assess the role of interventional radiotherapy (IRT, brachytherapy) in the management of primary and/or recurrent vulvar carcinoma. Evidence acquisition A systematic research using PubMed, Scopus and Cochrane library was performed. ClinicalTrials.gov was searched for ongoing or recently completed trials, and PROSPERO was searched for ongoing or recently completed systematic reviews. Only full-text English-language articles related to IRT for treatment of primary or recurrent VC were identified and reviewed. Conference paper, survey, letter, editorial, book chapter and review were excluded. Time restriction (1990–2018) as concerns the years of the publication was considered. Evidence synthesis Primary disease: the median 5-year LC was 43.5% (range 19–68%); the median 5-year DFS was 44.5% (range 44–81%); the median 5-year OS was 50.5% (range 27–85%). Recurrent disease: the median 5-year DFS was 64% (range 56–72%) and the median 5-year OS was 45% (range 33%-57%). Acute ≥ grade 2 toxicity was reported in three patients (1.6%). The severe late toxicity rates (grade 3–4) ranged from 0% to 14.3% (median 7.7%). Conclusion IRT as part of primary treatment for primary and/or recurrent vulvar cancer is associated with promising clinical outcomes (AU)

Terms, definitions and measurements to describe sonographic features of lymph nodes: consensus opinion from the Vulvar International Tumor Analysis (VITA) group.

In centers with access to high-end ultrasound machines and expert sonologists, ultrasound is used to detect metastases in regional lymph nodes from melanoma, breast cancer and vulvar cancer. There is, as yet, no international consensus on ultrasound assessment of lymph nodes in any disease or medical condition. The lack of standardized ultrasound nomenclature to describe lymph nodes makes it difficult to compare results from different ultrasound studies and to find reliable ultrasound features for distinguishing non-infiltrated lymph nodes from lymph nodes infiltrated by cancer or lymphoma cells. The Vulvar International Tumor Analysis (VITA) collaborative group consists of gynecologists, gynecologic oncologists and radiologists with expertise in gynecologic cancer, particularly in the ultrasound staging and treatment of vulvar cancer. The work herein is a consensus opinion on terms, definitions and measurements which may be used to describe inguinal lymph nodes on grayscale and color/power Doppler ultrasound. The proposed nomenclature need not be limited to the description of inguinal lymph nodes as part of vulvar cancer staging; it can be used to describe peripheral lymph nodes in general, as well as non-peripheral (i.e. parietal or visceral) lymph nodes if these can be visualized clearly. The association between the ultrasound features described here and histopathological diagnosis has not yet been established. VITA terms and definitions lay the foundations for prospective studies aiming to identify ultrasound features typical of metastases and other pathology in lymph nodes and studies to elucidate the role of ultrasound in staging of vulvar and other malignancies. © 2021 International Society of Ultrasound in Obstetrics and Gynecology.

The role of brachytherapy (interventional radiotherapy) for primary and/or recurrent vulvar cancer: a Gemelli Vul.Can multidisciplinary team systematic review.

OBJECTIVE: The aim of our systematic review was to assess the role of interventional radiotherapy (IRT, brachytherapy) in the management of primary and/or recurrent vulvar carcinoma. EVIDENCE ACQUISITION: A systematic research using PubMed, Scopus and Cochrane library was performed. ClinicalTrials.gov was searched for ongoing or recently completed trials, and PROSPERO was searched for ongoing or recently completed systematic reviews. Only full-text English-language articles related to IRT for treatment of primary or recurrent VC were identified and reviewed. Conference paper, survey, letter, editorial, book chapter and review were excluded. Time restriction (1990-2018) as concerns the years of the publication was considered. EVIDENCE SYNTHESIS: Primary disease: the median 5-year LC was 43.5% (range 19-68%); the median 5-year DFS was 44.5% (range 44-81%); the median 5-year OS was 50.5% (range 27-85%). Recurrent disease: the median 5-year DFS was 64% (range 56-72%) and the median 5-year OS was 45% (range 33%-57%). Acute ≥ grade 2 toxicity was reported in three patients (1.6%). The severe late toxicity rates (grade 3-4) ranged from 0% to 14.3% (median 7.7%). CONCLUSION: IRT as part of primary treatment for primary and/or recurrent vulvar cancer is associated with promising clinical outcomes.

Real-time ultrasound virtual navigation in 3D PET/CT volumes for superficial lymph-node evaluation: innovative fusion examination.

OBJECTIVE: To evaluate the feasibility and clinical application of fusion imaging with virtual navigation, combining 18 F-fluorodeoxyglucose (18 F-FDG) positron emission tomography/computed tomography (PET/CT) with real-time ultrasound imaging, in assessing superficial lymph nodes in breast-cancer and gynecological-cancer patients. METHODS: This was a pilot study of breast- and gynecological-cancer patients with abnormal uptake of 18 F-FDG by axillary or groin lymph nodes on PET/CT scan, examined at our institution between January 2017 and May 2019. Fusion imaging was performed, uploading preacquired PET/CT DICOM images onto the ultrasound machine and synchronizing them with real-time ultrasound scanning performed at the lymph-node site. In the first phase, we assessed the feasibility and reliability of fusion imaging in a series of 10 patients with suspicious lymph nodes on both PET/CT and ultrasound, and with full correspondence between both techniques in terms of size, shape and morphology of the lymph nodes (Group A). In the second phase, we included 20 patients with non-corresponding findings between PET/CT and ultrasound: 10 patients with lymph nodes that were suspicious or pathological on PET/CT scan but not suspicious on ultrasound assessment (Group B), and 10 patients with suspicious or pathological lymph nodes on both PET/CT and ultrasound but with no correspondence between the two techniques in terms of number of affected lymph nodes (Group C). RESULTS: In the 30 selected patients, fusion imaging was assessed at 30 lymph-node sites (22 inguinal and eight axillary nodes). In the first phase (Group A), the fusion technique was shown to be feasible in all 10 lymph-node sites evaluated. In the second phase, fusion imaging was completed successfully in nine of 10 cases in Group B and in all 10 cases in Group C. In all groups, fusion imaging was able to identify the target lymph node, guiding the examiner to perform a core-needle aspiration biopsy or to inject radiotracer for selective surgical nodal excision, according to the radio-guided occult lesion localization technique. CONCLUSION: Fusion imaging with virtual navigation, combining PET/CT and real-time ultrasound imaging, is technically feasible and able to detect target lymph nodes even when PET/CT and ultrasound findings are inconsistent. Fusion imaging can also be used to guide the performance of core-needle aspiration biopsy, avoiding further surgical diagnostic procedures, or the injection of radiotracer for selective surgical nodal excision, enabling more sparing, selective surgery. This innovative technique could open up multiple diagnostic and therapeutic opportunities in breast and gynecological oncology. © 2021 International Society of Ultrasound in Obstetrics and Gynecology.

Minimal residual disease at primary debulking surgery versus complete tumor resection at interval debulking surgery in advanced epithelial ovarian cancer: A survival analysis.

OBJECTIVES: To compare survival outcomes and peri-operative complications in patients with advanced ovarian cancer with 1-10 mm residual disease (RD) at primary debulking surgery (PDS) versus those achieving no gross residual disease (NGR) at interval debulking surgery (IDS). METHODS: Patients operated with the intent of complete cytoreduction for epithelial ovarian/fallopian tube/primary peritoneal cancer, FIGO stage IIIC-IV, RD 1-10 mm at PDS and NGR at IDS, between 01/2010 and 12/2016, were retrospectively included. All patients had at least 2-years of follow-up completed. RESULTS: 207 patients were included (59 PDS and 148 IDS). Patients in PDS group were younger and had a higher surgical complexity score. There was a higher rate of intra- and major early post-operative complications in the group of PDS vs IDS (16.9% vs 1.3% and 28.8% vs 2.0%, p < 0.0001 respectively). After a median follow up of 56.4 months (range 59.2-65.4), 117 (56.5%) patients died of disease in the whole population. Forty-eight (81.4%) patients had progression/recurrent disease in the PDS group and 120 (81.1%) in the IDS group. Median PFS was 16.2 months and 18.9 months for PDS and IDS group, respectively (p = 0.111). Median OS was 41.4 months and 52.4 months for PDS and IDS group, respectively (p = 0.022). CONCLUSIONS: IDS should be considered the preferred treatment in case millimetric residual disease is expected at PDS in view of the superimposable PFS and the reduced number of perioperative complications.

Ultrasound morphometric and cytologic preoperative assessment of inguinal lymph-node status in women with vulvar cancer: MorphoNode study.

OBJECTIVE: To assess the accuracy of preoperative ultrasound examination for predicting lymph-node (LN) status in patients with vulvar cancer. METHODS: This was a single-institution retrospective observational study of all women with a histological diagnosis of vulvar cancer triaged to inguinal surgery within 30 days following ultrasound evaluation between December 2010 and January 2016. For each groin examined, 15 morphological and dimensional sonographic parameters associated with suspicion for LN involvement were examined. A morphometric ultrasound pattern (MUP) was expressed for each groin, classifying the inguinal LN status into five groups (normal; reactive-but-negative; minimally suspicious/probably negative; moderately suspicious; and highly suspicious/positive) according to subjective judgment, followed by stratification as positive or negative for metastasis according to morphometric binomial assessment (MBA). In cases of positive MBA, fine-needle aspiration cytology was performed. Combining the information obtained from MUP and cytologic results, a binomial final overall assessment (FOA) was assigned for each groin. The final histology was considered as the reference standard. Comparison was performed between patients with negative and those with positive LNs on histology, and receiver-operating-characteristics curves were generated for statistically significant variables on univariate analysis, to evaluate their diagnostic ability to predict negative LN status. RESULTS: Of 144 patients included in the analysis, 87 had negative inguinal LNs and 57 had positive LNs on histology. A total of 256 groins were analyzed, of which 171 were negative and 85 showed at least one metastatic LN on histology. The following parameters showed the greatest accuracy, with the best balance between specificity and sensitivity, in predicting negative LN status: cortical (C) thickness of the dominant LN (cut-off, 2.5 mm; sensitivity, 90.0%; specificity, 77.9%); short-axis (S) length of the dominant LN (cut-off, 8.4 mm; sensitivity, 63.9%; specificity, 90.6%); C/medulla (M) thickness ratio of the dominant LN (cut-off, 1.2 mm; sensitivity, 70.4%; specificity, 91.5%), the combination of S length and C/M thickness ratio (sensitivity, 88.9%; specificity, 82.4%); and the FOA analysis (sensitivity, 85.9%; specificity, 84.2%). CONCLUSIONS: Preoperative ultrasound assessment, with or without the addition of cytology, has a high accuracy in assessing inguinal LN status in patients with vulvar cancer. In particular, the combination of two ultrasound parameters (S length and C/M thickness ratio) provided the greatest accuracy in discriminating between negative and positive LNs. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.

Fusion of ultrasound and 3D single-photon-emission computed tomography/computed tomography to identify sentinel lymph nodes in vulvar cancer: feasibility study.

OBJECTIVE: To evaluate the feasibility of fusion of ultrasound imaging and three-dimensional (3D) single-photon-emission computed tomography/computed tomography (SPECT/CT) in detecting sentinel lymph nodes in women with vulvar cancer. METHODS: This was a prospective pilot single-center study. Patients with vulvar cancer who were candidates for sentinel lymph-node biopsy were enrolled between December 2018 and February 2019. Fusion imaging virtual navigation using 3D SPECT/CT and ultrasound was performed to investigate the tumor-draining lymph node. All clinical, imaging, surgical and histological information was collected prospectively and entered into a dedicated Excel file. Feasibility and success of fusion imaging virtual navigation and time needed to perform the three steps of fusion imaging were evaluated. RESULTS: Ten lymph-node sites were evaluated in five consecutive women with a histological diagnosis of vulvar cancer. Fusion imaging virtual navigation was feasible and completed successfully for all (10/10) draining sites. Median overall time to perform fusion imaging was 32 (range, 25-40) min and the time decreased from the first to the last examination. CONCLUSIONS: The present study demonstrated that fusion imaging virtual navigation using 3D SPECT/CT and ultrasound is feasible and able to detect sentinel lymph nodes in women with vulvar carcinoma. Fusion imaging using ultrasound for detection of sentinel lymph nodes opens up multiple diagnostic and therapeutic opportunities in gynecological oncology. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.

The Role of Radiotherapy in Extramammary Paget Disease: A Systematic Review.

OBJECTIVE/PURPOSE: Extramammary Paget disease (EMPD) is a rare neoplasm of the skin generally affecting the anogenital area. Because of the low-frequency of the disease, no specific guidelines about the treatment strategy are available. Surgery is the recommended therapy for resectable and localized disease, but several other local treatments have been reported such as radiotherapy (RT). Most articles report small retrospective studies, referring to patients treated decades ago with large heterogeneity in terms of RT dose and technique. The aim of this study was to systematically review the main experiences in RT for the treatment of EMPD in the past 30 years. MATERIALS AND METHODS: A systematic search of the bibliographic databases PubMed and Scopus from January 1986 to January 2017 was performed including studies published in English, Italian, Spanish, French, and German language. RESULTS: According to the search strategy, 19 full-text articles, published from 1991 to 2015, fulfilled inclusion criteria and were included in the final review. All articles were retrospective analyses with no randomized controlled trials. These studies evaluated 195 EMPD patients treated with RT, delivered in several settings. A large variability in terms of RT doses, fractionation, clinical setting, and techniques was found.Radiotherapy was administered as definitive treatment for primary or recurrent disease after surgery in 18 studies with doses ranging from 30 to 80.2 Gy delivered in 3 to 43 fractions. Radiotherapy was administered as postoperative adjuvant treatment in 9 articles with doses ranging between 32 and 64.8 Gy in 20 to 30 fractions. Two studies reported the RT use in preoperative neoadjuvant setting with doses ranging between 40 and 43.30 Gy, and 2 experiences reported the RT treatment for in situ EMPD, using 39.6 to 40 Gy. Adverse events were reported in almost all but 2 articles and were grade 2 or lower.The 18 studies evaluating RT as definitive treatment for primary or recurrent disease after surgery reported a complete response rate ranging from 50% to 100%, with a variable rate of local relapse or persistent disease ranging from 0% to 80% of cases. The 9 studies evaluating RT as postoperative adjuvant treatment reported a local relapse or persistent disease rate of 0% to 62.5%. A dose-response relationship was reported suggesting doses greater than or equal to 60 Gy for gross tumor volume treatment. Local control, disease-free survival, and overall survival at 12, 20, and 60 months have been retrieved for available data, respectively.In patients with EMPD and concurrent underlying internal malignancy, the prognosis was often worsened by the latter. In this setting, literature analysis showed a potential RT palliative role for symptoms control or local control maintenance.Derma tumor invasion greater than 1 mm and lymph node metastases were reported to be important prognostic factors for distant metastases or death. CONCLUSIONS: To date, literature highlights the role of RT in the management of EMPD, but with low level of evidences.

Groin sentinel node biopsy and 18F-FDG PET/CT-supported preoperative lymph node assessment in cN0 patients with vulvar cancer currently unfit for minimally invasive inguinal surgery: The GroSNaPET study.

OBJECTIVE: The study aims were: 1) to verify the role of sentinel node biopsy (SNB) in a subset of patients with clinical N0 (cN0) invasive vulvar cancer (VC) who were still candidates for radical inguinal surgery according to the current guidelines; 2) to investigate whether a preoperative 18F-FDG PET/CT (PET/CT) evaluation could improve the selection of node negative patients. METHODS: From July 2013 to July 2016, all patients with VC admitted to our Division were evaluated by standard imaging and clinical exam. Among the patients assessed as cN0 we enrolled those unsuitable for SNB, due to: T > 4 cm, multifocal tumors, complete tumor diagnostic excision, contralateral nodal involvement and local recurrence. A preoperative PET/CT was performed. For each patient surgery included SNB, performed using a combined technique (radiotracer plus blue dye), followed by standard inguino-femoral lymphadenectomy. The reference standard was histopathology. RESULTS: Forty-seven patients entered the study for a total of 73 groins. Histopathology revealed 12 metastatic SNs in 9 groins. No false negative SNs were found (NPV 100%). PET/CT showed a negative predictive value of 93%. CONCLUSIONS: Our data suggest that SNB is accurate and safe even in cN0 patients currently excluded from this procedure, providing that a careful preoperative selection is performed. PET/CT allows a reliable assessment of LN status and may be an effective support for the selection of patients who are safe candidates for SNB.

Role of CT scan-based and clinical evaluation in the preoperative prediction of optimal cytoreduction in advanced ovarian cancer: a prospective trial.

BACKGROUND: In advanced ovarian cancer, maximal efforts have to be attemptedto achieve optimal cytoreduction, as this represents the keystone in the therapeutic management. This large, prospective study aims at investigating the role of computed tomography (CT) scan in predicting the feasibility of optimal cytoreduction in ovarian cancer. METHODS: A total of 195 consecutive patients with clinical/radiographic suspicion of advanced ovarian/peritoneal cancer were enrolled at the Gynecologic Oncology Unit, Catholic University of Rome and Campobasso, Italy. Preoperative CT scans were performed with a high-speed scanner (CT Hi Speed Nx/i Pro; 2-slice; GE Medical System). All patients underwent standard laparotomy, and maximal surgical effort was attempted. The following CT parameters were used: peritoneal thickening, peritoneal implants >2 cm, bowel mesentery involvement, omental cake, pelvic sidewall involvement and/or hydroureter, suprarenal aortic lymph nodes >1 cm, infrarenal aortic lymph nodes >2 cm, superficial liver metastases >2 cm and/or intraparenchimal liver metastases any size, large volume ascites (>500 ml). Clinical data included were age, Ca125 serum levels, and ECOG-PS. Radiographic and clinical features exhibiting a specificity >75%, a positive and negative predictive value >50%, an accuracy >60% in predicting surgical outcome were assigned a point value of 2. With this scoring system, a predictive index (PI) was calculated for each patient. RESULTS: The PI scores ranged from 0 to 6, and from 0 to 8, in Model 1 (including only radiographic parameters) and in Model 2 (including radiographic and clinical data). The AUC was 0.78+0.035 in Model 1, and 0.81+0.031 in Model 2. Therefore, the addition of ECOG-PS data led to the improvement of the diagnostic performances (z=2.41, P-value <0.05). CONCLUSIONS: Computed scan still represents a valid tool to predict ovarian cancer optimal cytoreduction; the predictive ability of a CT scan-based model is improved by integrating ECOG-PS data.

Cisplatin and vinorelbine as neoadjuvant chemotherapy in locally advanced cervical cancer: a phase II study.

Fifty eight consecutive untreated patients with locally advanced cervical carcinoma (LACC) received neoadjuvant chemotherapy (NACT) with cisplatin (CDDP) 80 mg/sqm (day 1) + vinorelbine (VRL) 25 mg/sqm (day 1 and 8). Three cycles of chemotherapy were planned every 21 days. Within 28 days from the completion of chemotherapy patients in complete or partial response were submitted to radical hysterectomy with pelvic lymphadenectomy. On 155 cycles, hematologic toxicity was mild (G3-4 neutropenia and anemia occurred in 16% and 5%, respectively). Forty-seven patients (81%) were submitted to radical surgery; eight (14%) patients were deemed ineligible for surgery because of poor response to treatment, two (3%) for anesthesia contraindications and one (2%) refused surgery. At pathologic examination 12 patients (25%) had a complete response, one (2%) in-situ carcinoma, six (13%) residual microinvasive disease, and 28 (60%) a partial response. None had extracervical disease. Eight patients (14%) had microscopic lymph node metastases. The number of cycles administered was significantly associated with a good pathologic response. Association of CDDP and VRL as NACT in LACC appears safe and effective. Low cost and modest toxicity would support the initiation of a multicenter randomized phase III trial to compare this association with cisplatin alone.